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This study will establish a normative database of Tilmanocept Uptake Values (TUVjoint) in healthy controls age-matched to the RA population.
Full description
This is a prospective, open-label, multicenter, single-dose study designed to develop a normative database of TUVjoint in HCs and to assess the feasibility of qualitative and quantitative SPECT/CT assessments in HCs and subjects with active RA.
This study is stratified into 2 arms. Arm 1 is comprised of HCs and Arm 2 is comprised of HCs and clinically diagnosed RA subjects on stable treatment.
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Inclusion criteria
ALL SUBJECTS
The subject has provided written informed consent with HIPAA (Health Information Portability and Accountability Act) authorization before the initiation of any study-related procedures.
The subject has agreed to not engage in any diet, lifestyle, or medication changes until study completion.
HEALTHY CONTROL SUBJECTS
The subject is 30 years of age or greater at the time of consent.
The subject is deemed to be clinically free of any inflammatory disease(s), autoimmune disease(s), or arthropathies and has not experienced joint pain for at least 28 days prior to the consent date.
The subject is not currently on anti-inflammatory drugs (including non-steroidal anti-inflammatory drugs [NSAIDs]) and has not taken any anti-inflammatories for at least 28 days prior to the consent date.
For all ongoing concomitant medications, the subject has maintained a stable dose for at least 28 days prior to the consent date.
CLINICALLY DIAGNOSED ACTIVE RA SUBJECTS
The subject is at least 18 years of age and was ≥ 18 years of age at the time of RA diagnosis.
The subject has moderate to severe RA as determined by the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Classification Criteria (score of ≥ 6/10).
The subject has a 28-joint disease activity score (DAS28) of ≥ 3.2 (includes the Erythrocyte Sedimentation Rate [ESR] test and Visual Analog Scale [VAS]).
Subjects receiving traditional DMARDs must have been on therapy for ≥ 90 days and at a stable dose for ≥ 30 days prior to the imaging visit (Day 0). 7. If the subject is receiving bDMARD or janus kinase (JAK) inhibitor therapy, they have been at a stable dose > 60 days prior to the imaging visit (Day 0). 8. If the subject is receiving NSAIDs or oral corticosteroids, the dose has been stable for ≥ 28 days prior to the imaging visit (Day 0). The corticosteroid dose must be ≤ 10 mg/day of prednisone or an equivalent steroid dose.
Exclusion criteria
Primary purpose
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Interventional model
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135 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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